U.S. patent number 5,139,489 [Application Number 07/663,454] was granted by the patent office on 1992-08-18 for needle protection device.
This patent grant is currently assigned to Smiths Industries Medical Systems, Inc.. Invention is credited to William H. Hollister.
United States Patent |
5,139,489 |
Hollister |
August 18, 1992 |
Needle protection device
Abstract
To be used with a double-ended needle assembly and to prevent
the accidental pricking of user, or others, in a first embodiment
of the present invention, a container holder mated with the needle
assembly has a protective housing integrally and flexibly connected
thereto. To prevent a contaminated needle from posing a risk to the
user and others, the housing connected to the container holder is
pivoted into alignment with the contaminated needle such that the
needle is retained by at least one locking mechanism integral of
the housing. The container holder, along with the contaminated
needle assembly, can then be disposed of. If the container holder
were to be reused, a second embodiment of the present invention
provides for the connection of a protective housing to the hub of a
double-ended needle assembly. For this embodiment, after use, the
contaminated needle assembly, after having been properly retained
in the protective housing, is removed from the reusable container
housing and disposed of. Another embodiment of the invention
relates to integrally and flexible connecting a protective housing
to an adapter, which is interposed between the double-ended needle
assembly and the container holder. Variants of the invention
include a collapsible housing having a sealer therein which may be
used to sealingly secure the tip of the contaminated needle and a
collapsible hinge which likewise is used to effect the securing of
the tip of the contaminated needle in a sealer adapted to the
distal end portion of the housing.
Inventors: |
Hollister; William H. (Nelson,
NH) |
Assignee: |
Smiths Industries Medical Systems,
Inc. (Keene, NH)
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Family
ID: |
25206154 |
Appl.
No.: |
07/663,454 |
Filed: |
March 4, 1991 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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637714 |
Jan 7, 1991 |
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Current U.S.
Class: |
604/192;
600/576 |
Current CPC
Class: |
A61M
5/3216 (20130101); A61B 5/15003 (20130101); A61B
5/154 (20130101); A61B 5/150671 (20130101); A61B
5/150732 (20130101); A61B 5/150496 (20130101); A61M
2005/3109 (20130101); A61B 5/150389 (20130101); A61B
5/150572 (20130101) |
Current International
Class: |
A61M
5/32 (20060101); A61M 5/31 (20060101); A61M
005/32 () |
Field of
Search: |
;128/760,763,770
;604/192,198 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Hindenburg; Max
Attorney, Agent or Firm: Pollock, Vande Sande &
Priddy
Parent Case Text
This is a Continuation-In-Part application of patent application
Ser. No. 637,714, abandoned filed Jan. 7, 1991.
Claims
I claim:
1. A safety device to be used with a needle assembly having a first
end for invasively contacting a body and a second end for
communicating with a container, comprising:
a holder having a hollow main body section and a receptacle end
extending therefrom, said holder further having an open end through
which at least a portion of said container is inserted into said
main body section, said receptacle end of said holder being mated
with said second end of said needle assembly such that at least a
portion of said second end extends into said main body section to
be in communication with said inserted portion of said container to
provide a conduit to said container for fluid passage between said
body and said container;
housing means flexibly connected to said holder, and pivotable
toward a position in substantial alignment along the longitudinal
axis of said needle assembly for enveloping said first end of said
needle assembly, said housing means including locking means for
substantially fixedly retaining said first end of said needle
assembly within said housing means once said housing means has been
pivoted to said position.
2. Safety device of claim 1, wherein said housing means comprises a
longitudinal sheath having an elongated slot through which said
first end of said needle assembly passes when said sheath is
pivoted to said position.
3. Safety device of claim 1, wherein said locking means comprises
at least one hooking means integral of said housing means for
substantially retaining said first end of said needle assembly
within said housing means.
4. Safety device of claim 1, wherein said housing means is
integrally connected to said receptacle end of said holder by a
hinge means.
5. Safety device of claim 1, wherein said housing means is further
connected to said main body section of said holder.
6. Safety device of claim 1, further comprising a substantially
rigid shoulder member extending from said holder to flexibly
connect said housing means.
7. Safety device of claim 1, wherein said container comprises a
fluid collection tube having an internal pressure lower than the
ambient atmospheric pressure such that, when said conduit is
provided between said tube and said body, fluid from said body is
drawn and collected in said tube.
8. Safety device of claim 1, wherein said needle assembly comprises
a hub; and
wherein said receptacle end of said holder is internally threaded
for threadedly mating with said hub of said needle assembly.
9. Safety device of claim 1, wherein said housing means includes at
least a cap portion and a main portion from which said housing
means is connected to said holder, further comprising:
a collapsible section integrally interposed between said cap and
main portions; and
means adapted to said cap portion of said housing means to
substantially sealingly secure the tip of said first end of said
needle assembly after said housing means has been pivoted to said
substantial alignment position and said cap portion and said main
portion have been relatively urged toward each other to thereby
collapse said collapsible section.
10. Safety device of claim 1, wherein said housing means includes a
cap portion, further comprising:
sealing means adapted to said cap portion of said housing means;
and
wherein said housing means is integrally connected to said holder
by a collapsible hinge means such that, after said housing means
has been pivoted via said hinge means to substantially align along
the longitudinal axis of said needle assembly to envelop said first
end of said needle assembly, and said housing means and said holder
have been relatively urged toward each other to collapse said hinge
means, the tip of said first end of said needle assembly would
penetrate into said sealing means and be substantially sealingly
secured thereby.
11. A safety device for a double-ended needle assembly having
opposed cannula portions, comprising:
a holder having a hollow main body section and a receptacle end
extending therefrom, said holder further having an open end through
which at least a portion of a container is insertable into said
main body section, said receptacle end of said holder being mated
with said needle assembly such that at least a portion of one of
said opposed cannula portions of said needle assembly extends into
said main body section to be in communication with said insertable
portion of said container;
housing means flexibly connected to said holder, and pivotable
toward a position in substantial alignment along the longitudinal
axis of said needle assembly for enveloping the other of said
opposed cannula portions, said housing means including locking
means for substantially fixedly retaining said other of said
opposed cannula portions within said housing means once said
housing means has been pivoted to said position.
12. Safety device of claim 11, wherein said housing means comprises
a longitudinal sheath having an elongated slot through which said
other of said opposed cannula portions passes when said sheath is
pivoted to said position.
13. Safety device of claim 11, wherein said locking means comprises
at least one hooking means integral of said housing means for
substantially preventing relative motion between said other of said
opposed cannula portions and said housing means.
14. Safety device of claim 11, wherein said housing means is
further integrally connected to said receptacle end of said holder
by a hinge means.
15. Safety device of claim 11, further comprising a substantially
rigid shoulder member extending from said holder to flexibly
connect said housing means.
16. Safety device of claim 11, wherein said housing means includes
at least a cap portion and a main portion from which said housing
means is connected to said holder, further comprising:
a collapsible section integrally interposed between said cap and
main portions; and
means adapted to said cap portion of said housing means to
substantially sealingly secure the tip of said other of said
opposed cannula portions after said housing means has been pivoted
to said substantial alignment position and said cap portion and
said main portion have been relatively urged toward each other to
thereby collapse said collapsible section.
17. Safety device of claim 11, wherein said housing means includes
a cap portion, further comprising:
sealing means adapted to said cap portion of said housing means;
and
wherein said housing means is integrally connected to said holder
by a collapsible hinge means such that, after said housing means
has been pivoted via said hinge means to substantially align along
the longitudinal axis of said needle assembly to envelop said other
of said opposed cannula portions, and said housing means and said
holder have been relatively urged toward each other to collapse
said hinge means, the tip of said first end of said needle assembly
would penetrate into said sealing means and be substantially
sealingly secured thereby.
Description
FIELD OF THE INVENTION
This invention relates to co-pending application Ser. No. 532,558,
entitled "Safety Needle Container", filed Jun. 4, 1990, now U.S.
Pat. No. 4,982,842, by the same inventor and assigned to the same
assignee as the instant invention. The disclosure of the '842
Patent is hereby incorporated to this application by reference.
This invention is further related to co-pending application Ser.
No. 561,459, entitled "Safety Needle Container", filed Aug. 1, 1990
by the same inventor and assigned to the same assignee as the
instant invention. The disclosure of the '459 application is also
hereby incorporated to this application by reference.
Specifically, the present invention is related to a protective
device which can be used with a fluid holding tube and, more
specifically, a protective device to prevent a user, or a
bystander, from being accidently pricked by the sharp end of a
needle assembly that is used in conjunction with the fluid
collection tube.
BACKGROUND OF THE INVENTION
In the '558 and '459 applications, different protective devices to
be used with a hypodermic needle are disclosed. As enunciated
therein, protective devices for preventing a user, or for that
matter a bystander, from being accidently pricked by the sharp end
of an exposed needle are urgently needed, particularly in view of
the current epidemic of infectious diseases resulting from sharing
of, and possibly accidentally pricking by, contaminated
needles.
In the case where a double-ended needle assembly is used with a
fluid collection system, for example an evacuated blood collection
tube, the risk of a user, i.e. a phlebotomist, of accidentally
puncturing himself with a contaminated needle is magnified,
inasmuch as, ordinarily, the user has to recap the used
double-ended needle assembly before removing it from the container
holder, which holds the evacuated blood collection tube. Thus, the
user has to, in a two-handed operation, first carefully align a
protective sheath with the exposed contaminated needle before he is
able to cover the latter with the former. As should readily be
apparent, if the user is in a hurry, or is distracted as for
example in emergency room situations, there is a good chance that
he may miss aligning the sheath with the exposed needle and be
accidentally pricked thereby, and therefore exposed to the risk of
contracting blood-borne infectious diseases.
The double-ended needle assembly oftentimes is removed from the
container holder, which is reusable. According to workers skilled
in this area of the medical field, some of the reasons given for
reusing a container holder include: (1) the extra cost of using a
new container holder for each patient; (2) the desire not to
clutter up the environment with extra trash; and (3) it is easier
for a phlebotomist to carry and use one container holder for all
patients, instead of having to carry many container holders and
using a new one for each patient.
SUMMARY OF THE PRESENT INVENTION
To eliminate as much as possible the possibility of a user, or a
bystander, from being accidentally pricked by a contaminated
needle, the inventor proposes, in a first embodiment, that a
protective housing (or sheath) with integral locking mechanisms be
connected to the fluid container holder such that the housing may
be pivoted to envelop the contaminated needle and permanently
retain the needle within the housing with the locking
mechanisms.
A second embodiment of the present invention connects a protective
housing to the hub of a double-ended needle assembly such that the
needle assembly--including the housing after the same has been
pivoted to permanently retain the contaminated needle--may be
thrown out after use, if the container holder is to be reused.
A third embodiment of the present invention integrates a protective
housing to an adapter to be interposed between a container holder
and a needle assembly such that, once the housing has been pivoted
to envelop and retain the contaminated needle, the adapter and the
attached needle assembly are both removed and discarded, were the
container holder to be reused.
A fourth embodiment of the present invention integrates a
protective housing to a base, which is to mate with the outer
circumferential portion of the receptacle end of a reusable
container holder. There are two variants to this embodiment. The
first variant envisions the fittingly mating of the base of the
protective housing directly to the receptacle end of the holder.
The second variant envisions the receptacle end being externally
threaded and the base correspondingly internally threaded, so that
the base can threadedly mate with the receptacle end. In either of
the variants, the double-ended needle assembly is threadedly mated
through an aperture in the base to the inner circumferential
threads of the receptacle end. After use both the needle assembly
and the protective housing are removed from the container holder at
the same time and disposed of.
With the above-noted different embodiments, it is further
envisioned that a collapsible (also can be compressible or
crushable) section be integrated somewhere along the housing and a
sealing material adapted to the distal end of the housing so that
the tip of the exposed needle of the needle assembly would
penetrate into and be sealingly secured within the sealing
material, to thereby ensure that not only is the tip of the
contaminated needle not exposed, but that it is also completely
sealed.
An alternative to integrating a collapsible section somewhere along
the length of the housing is to connect the housing to the holder
with a collapsible (compressible or crushable) hinge. Thus, by
moving the housing relative to the fluid container holder in the
first embodiment, the double-ended needle assembly in the second
embodiment, or the adapter in the third embodiment, the tip of the
contaminated needle is sealingly secured by the sealing material
adapted to the distal end of the housing.
It is, therefore, an objective of the present invention to provide
a one piece combination container holder and protective
housing/sheath that requires only one-handed operation, and
provides for excellent protection to a user or bystander.
It is another objective of the present invention to provide a
needle assembly that has its own integral protective housing to
thereby eliminate the need for an adapter.
It is yet another objective of the present invention to provide a
safety adapter that, along with a contaminated needle assembly, may
be safely removed from a container holder, thereby allowing the
container holder to be reused.
It is still another objective of the present invention to provide a
needle protection device that can substantially sealingly secure
the tip of a contaminated needle to thus further enhance the safety
integrity of the device.
BRIEF DESCRIPTION OF THE DRAWINGS
The above-mentioned objectives and advantages of the present
invention will become more apparent and the invention itself will
be best understood by reference to the following description of
embodiments of the present invention taken in conjunction with the
accompanying drawings, wherein:
FIG. 1 is a side view of a first embodiment of the safety device of
the present invention in alignment with a fluid collection tube and
a double-ended needle assembly;
FIG. 2A is a plan view of the protective housing shown in the FIG.
1 embodiment;
FIG. 2B is a cross-sectional cut-away view, along line A--A, of the
FIG. 2A protective housing;
FIG. 2C is a cross-sectional cut-away view, along line B--B, of the
FIG. 2A protective housing;
FIG. 3 is a second embodiment of the present invention showing a
needle assembly having integrally connected thereto a protective
housing;
FIG. 4 is another embodiment of the present invention utilizing an
adapter, with an integrally connected protective housing, to be
interposed between a needle assembly and a fluid container
holder;
FIG. 5A is a plan view of another embodiment of the protective
housing of the present invention in which a collapsible section is
integrally interposed between an end cap portion and a main portion
of the housing, and a sealing means having been adaptedly fitted to
the cap portion of the housing;
FIG. 5B is a side view of the FIG. 5A protective housing;
FIG. 5C is a plan view of the FIG. 5A housing whose collapsible
section has collapsed due to the relative movement of the end
portion and main portion of the housing toward each other;
FIG. 6 is a side view of a variation of the FIG. 1 embodiment
having the FIG. 5A protective housing;
FIG. 7 is a variation of the FIG. 3 embodiment with a FIG. 5A
protective housing;
FIG. 8 is a variation of the FIG. 4 embodiment which has a FIG. 5A
protective housing;
FIG. 9 is yet an another variation of the FIG. 1 embodiment having
incorporated thereto a collapsible hinge;
FIG. 10 is another variation of the FIG. 3 embodiment whose hinge
is collapsible;
FIG. 11 is a variation of the FIG. 4 embodiment, with a collapsible
hinge connecting the housing to the adapter;
FIG. 12A is a semi-exposed frontal view of yet another embodiment
of the present invention;
FIG. 12B is a semi-exposed side view of the FIG. 12A
embodiment;
FIG. 12C is a cross-sectional view along cut C--C of FIG. 12B;
FIG. 13A is a semi-exposed frontal view of a variant of the FIG. 12
embodiment;
FIG. 13B is a semi-exposed side view of the FIG. 13 variant;
FIG. 13C is a cross-sectional view of cut D--D as shown in FIG.
13B;
FIG. 14A is a semi-exposed frontal view of a variant of the FIG. 12
embodiment where the base portion of the housing is fittingly mated
to the receptacle end of the container housing; and
FIG. 14B is a semi-exposed side view of the FIG. 14A variant
embodiment.
DETAILED DESCRIPTION OF THE INVENTION
A first embodiment of the present invention, with reference to FIG.
1, shows a fluid container holder 2 having a hollow main body
section 4 and a receptacle end 6 integrally extending therefrom. An
aperture extends from opening 5 of receptacle end 6 into cavity 8
of main body section 4. The inner circumference of receptacle 6 is
threaded.
Integrally connected to main body section 4, and a portion of
receptacle end 6, is a substantially rigid shoulder member 10
extending longitudinally in parallel relationship to longitudinal
axis 12. At the distal end 14 of shoulder member 10 there is
connected, via a hinge means such as living hinge 16, a protective
housing or sheath 18. It should be appreciated that instead of
utilizing shoulder member 10, hinge 16 can directly connect housing
18 to either receptacle end 6 or main body section 4, or both,
since each of the respective lengths of both hinge 16 and housing
18 may be varied to suit different circumstances, i.e. differences
in the length of the needles to be enveloped . A more detailed
discussion of housing 18 is to be given with reference to FIGS.
2A-2C. A variant of housing 18 is further to be discussed with
reference to FIGS. 5A to 5C.
Also shown in alignment along longitudinal axis 12 is a
double-ended needle assembly 20 that includes a first needle
portion (cannula) 22 and an opposed needle portion (cannula) 24. A
needle hub 26 which comprises a protruding portion 28 and a
threaded portion 30 is molded about the double-ended needle
portions 22 and 24, as shown in FIG. 1. Connected to the lowermost
end of threaded portion 30 and covering cannula 24 is a rubber
sheath 32.
Container holder 2 further has an open end 34 through which a fluid
container tube 36 may be passed into cavity 8 of main body section
4. Container 36 has intimately fitted thereto, at its open end, a
rubber stopper 38. Ordinarily most of the air in the container tube
has been evacuated such that a vacuum exists within chamber 40 of
tube 36. Putting it differently, the pressure inside chamber 40 of
tube 36 has a lower pressure than the ambient atmospheric
pressure.
For venipuncture operation whereby blood is drawn from a patient,
needle assembly 20 is threadedly mated with receptacle 6, via
threaded portion 30 and internal threads 42, respectively. Once
thus mated, as should readily be apparent, at least a portion of
cannula 26 of needle assembly 20 would extend into cavity 8 of main
body section 4 of holder 2. At this point the phlebotomist would
insert (or invasively contact) the exposed cannula 22 into the vein
of the patient. Consequently, blood passes, mostly due to venous
pressure, through cannulas 22 and 24 of needle assembly 20. Sheath
32 prevents blood from escaping from the needle assembly into
cavity 8 of holder 2.
Once cannula 22 has properly penetrated the patient, to collect, in
this instance, blood from the patient, the phlebotomist would
insert fluid container tube 36, through open end 34, into cavity 8
of holder 2 such that rubber stopper 38 pushes rubber sheath 32
forward away from cannula 24. At the same time, rubber stopper 38
is pierced by cannula 24. As cannula 24 pierces through rubber
stopper 38, since chamber 40 is in essence a vacuum chamber, the
blood to be collected from the patient is drawn into chamber 40. As
is well known, a number of container tubes may be used to collect
multiple tubes of blood from the patient.
As is further well known, the apparatus shown in FIG. 1 may also be
used to collect fluids, other than blood, from a living body. For
example, urine and amniotic fluids may be withdrawn from a patient
by using the same double-ended type needle assembly, albeit with
different lengths. Further, instead of an evacuated container tube
such as 36 shown in FIG. 1, a fluid container tube in the form of a
vial containing medicament may be inserted into cavity 8 of holder
2 such that, with the help of a plunger, the medicament may be
forced into the patient. Thus, holder 2 shown in FIG. 1 is adapted
to be used to enable fluid passage (both ways) between the patient
and a fluid container tube.
When an appropriate amount of fluid has been either withdrawn from
or fed to the patient, cannula 22 is withdrawn from the patient. At
this time, to ensure that the user, or a bystander, would not be
accidently punctured by contaminated cannula 22, housing 18 is
pivoted about distal end 14, via hinge 16, such that it comes into
alignment with needle assembly 22, i.e. along longitudinal axis 12.
As housing 18 comes into alignment with cannula 22, the locking
mechanisms, in the form of hooks 44 and 46 integral within housing
18, would first bias against and then snap over cannula 22 to
thereby fixedly retaining the contaminated cannula within housing
18. Accordingly, accidental pricking by an exposed contaminated
cannula is prevented.
With reference to the plan view of housing 18 shown in FIG. 2A, it
can be seen that longitudinal housing 18 has an elongated slot 48,
bounded by sides 50 and 52, running substantially in parallel along
the length of the housing, which has a tip 54 at the cap (or apex)
portion of the housing and a base 56 supporting the main portion of
the housing. (For a one-handed operation, a user would push the cap
portion against a stationary object to pivot housing 18 into
alignment with cannula 22.) Further shown on housing 18 are
openings 58 and 60, at whose respective centers are integrally
formed locking mechanisms 46 and 44. Locking mechanisms 44 and 46
each have a substantially rigid finger 44a, 46a.
As more clearly shown by the cross-sectional FIG. 2C view of
locking mechanism 44, as housing 18 is pushed into alignment with
cannula 22, cannula 22 is first biased against finger 44a. But as
cannula 22 is pushed past tip 44t of finger 44a, the previously
biased finger 44a would spring back into its natural position to
thereby retain cannula 22 within the space between finger 44a and
extension 44c and substantially prevent relative movement between
cannula 22 and housing 18.
FIG. 2B is a cross-sectional view, along cut A--A of FIG. 2A, of
housing 18 which shows that fingers 46a and 44a extend in opposite
downwardly sloped directions. Such a construction makes it more
difficult for a retained contaminated cannula from being forcibly
removed from the housing.
A second embodiment of the present invention is envisioned for
those instances where it may be desirable to reuse the same
container holder. Specifically, with reference to FIG. 3, it can be
seen that a housing 18 has now been integrally and flexibly
connected to a base, or hub, 62 of a double-ended needle assembly
64 via a living hinge 65. Needle assembly 64 comprises a threaded
portion 66, which is to threadedly mate with a receptacle end of a
container holder, such as holder 2 (sans housing 18 connected
thereto) shown in FIG. 1. The same operation as that discussed
previously with reference to FIG. 1 is repeated herein with the
notable exception that instead of disposing container holder 2 as
was the case in the first embodiment, for the FIG. 3 embodiment,
once housing 18 has been pivoted into alignment with cannula 68 so
that the same is substantially fixedly retained within housing 18,
needle assembly 64--and of course housing 18 integral thereof, may
be removed from the receptacle end of the container holder and
disposed of. The FIG. 3 embodiment is more cost effective than the
FIG. 1 embodiment insofar as the container holder is now
reusable.
Yet another embodiment of the present invention is illustrated in
FIG. 4. There it can be seen that an adapter 70 comprises a section
72 and a smaller section 74 integrally extending therefrom. Adapter
70 is to be interposed between a fluid container holder 76 and a
needle assembly such as 20 shown in FIG. 1. To accommodate needle
assembly 20, the inner circumference of section 72 is threaded so
that threaded portion 30 of needle assembly 20 (see FIG. 1) may be
threadedly mated with the internal threads (indicated by dash lines
78) of section 72. To mate with container holder 76, external
threads (indicated by dash lines 80) are used to threadedly mate
with corresponding internal threads of receptacle end 82 of
container holder 76. Once needle assembly 20 has been threadedly
mated with section 72 and receptacle end 82 threadedly mated with
section 74, the operation of the FIG. 4 embodiment proceeds as was
discussed previously.
For the FIG. 4 embodiment, however, housing 18 is integrally and
flexibly connected to section 72 of adapter 70 via a living hinge
84. After the contaminated cannula has been withdrawn from the
patient, to prevent accidental pricking, housing 18 is, like the
previous embodiments, pivoted into alignment with the contaminated
cannula and snapped into a retention relationship, with locking
mechanisms 44 and 46, within housing 18. To dispose of the
contaminated needle assembly, adapter 70 is removed from container
holder 76. For this embodiment, container holder 76 is likewise
reusable.
With reference to FIGS. 5A--5C, a variant of the FIG. 2A housing
may also be used with the instant invention to further ensure that
the tip of the exposed needle (or cannula) is sealingly secured,
and therefore not exposed, even in highly unlikely circumstances
where the protective housing may not properly retain the
contaminated needle--as for example when the housing is cracked or
the locking mechanisms malfunctioned. For this variant, the same
elements, or those performing the same functions, as the
embodiments shown in FIGS. 1-4 are labelled the same.
As illustrated in FIG. 5A, variant housing 18 has a substantially
longitudinal collapsible (compressible or crushable)
accordion-shaped section 90 interposed between and integrally
connecting the main portion and a cap portion 92 of housing 18. For
purposes of explanation, the main portion of housing 18 extends
from base 56 to a partition 61 at the end of opening 60. If the
housing is a single piece molded sheath, manufactured for example
from plastic, collapsible section 90 may be an integral part of
housing 18 which integrally extends from partition 61 to edge 96 of
cap, or apex, portion 92. Alternatively, collapsible section 90 may
be made of materials different from that of the m in portion of
housing 18, or cap portion 92, as for example foldable cardboard or
fibered paper.
Although collapsible section 90 is shown as accordion-shaped, it
should be appreciated that other shaped collapsible sections may
also be used so long as section 90 may collapse (or be compressed)
to reduce the distance separating cap portion 92 (or more
accurately edge 96 of cap portion 92) and partition 61, as relative
movement urging the main portion of housing 18 and cap portion 92
toward each other is effected.
Adapted to and fitted within cap portion 92 is a sealing material
94 which may be, for example, a malleable elastomer, a piece of
rubber or some other suitable material which can sealingly secure
and firmly grip a sharp object that penetrates therein, as for
example tip 98 of needle 22 Materials such as cork or wax may also
be used. It should further be appreciated that tip 54 of cap
portion 92 is made of a material such as hard plastic that is
substantially impervious to penetration by sharp objects such as,
for example, tip 98 of needle 22. As was discussed previously, the
length of housing 18, which extends from base 56 to tip 54, may
vary depending on the length of needle 22, and is such that
clearance is provided in the space within collapsible section 90 to
allow a needle of a given length to pass unobstructed through
opening 52, when housing 18 is pivoted to substantially align along
the longitudinal axis of needle 22 and to envelop the same.
Assume that housing 18 has been pivoted into alignment with the
longitudinal axis of needle 22 and that needle 22 has in turn been
retained by locking mechanism 44. As best shown in FIG. 5C, when
relative movement for urging cap portion 92 toward the main portion
of housing 18 is effected, as for example illustrated by the
reduction of distance between partition 61 and edge 96, collapsible
section 90 collapses to thereby allow tip 98 of needle 22 to
penetrate into sealing material 94 and be substantially sealingly
secured thereby. The relative movement between the main portion of
housing 18 and cap portion 92 may be effected by a single-handed
operation of pushing tip 54 of housing 18 against some immobile
object. FIG. 5B is a side view of the FIG. 5A housing.
As shown in FIGS. 6, 7 and 8, the respective housings of the
embodiments of FIGS. 1, 3 and 4 have been replaced by the FIG. 5A
variant housing. Each of the alternative embodiments of FIGS. 6, 7
and 8 would, of course, provide the additional safety feature of
sealingly securing the tip of a contaminated needle, after variant
housing 18 has been pivoted into alignment with the contaminated
needle and cap portion 92 is urged against the tip of the needle
such that the tip of the needle is sealingly secured by sealing
material 94 fitted within cap portion 92.
In place of a housing having a main portion jointed to a cap
portion by a collapsible section, an alternative embodiment of
providing for the secure retention of the tip of a contaminated
needle may be had with reference to FIGS. 9, 10 and 11. Again,
components in FIGS. 9, 10 and 11 which are similar to, or perform
similar functions as, those discussed earlier are labelled the
same.
With specific reference to FIG. 9, which is a modification of the
FIG. 1 embodiment, it can be seen that housing 18, which is a
unitary piece, is flexibly connected to distal end 14 of shoulder
member 10 by a collapsible hinge means such as collapsible living
hinge 100. Although unitarily constructed, housing 18 nonetheless
has a cap portion 92 within which a sealing material 94 is
fitted.
As can easily be understood, after housing 18 has been pivoted into
alignment position along the longitudinal axis of needle 22, a
relative movement may be effected to urge housing 18 and container
holder 2 toward each other s that collapsible hinge 100 would
collapse, thereby allowing tip 98 of needle 22 to pierce and
penetrate into sealing material 94 and be sealingly secured
thereby. As should be appreciated, it is not necessary that
shoulder member 10 be present, as collapsible hinge 100 may be
directly connected to container holder 2, at receptacle end 6 or
otherwise.
As shown in FIG. 10, housing 18 of a needle assembly 64 is flexibly
connected to needle hub 62 by a collapsible living hinge 102.
Adapted to cap portion 92 of housing 18 is a sealing material 94
which sealingly secures tip 104 of cannula 68, after housing 18 has
been pivoted to align along the longitudinal axis of cannula 68 and
housing 18 and hub 62 are urged relatively toward each other to
collapse collapsible hinge 102, and to thereby cause tip 104 to
penetrate into sealing material 94.
With reference to FIG. 11, the adapter embodiment of the present
invention is shown to have its housing 18 connected to member 70 by
a collapsible living hinge 106. As was the case with the FIGS. 9
and 10 embodiments, adapted and fitted to a cap portion 92 of
housing 18 is a sealing material 94 which likewise is used to
sealingly secure the tip of a contaminated needle assembly, which
is threadedly mated to member 70, as was discussed previously with
reference to the discussion of the FIGS. 10 and 11 embodiments.
Yet another embodiment of the present invention is shown with
reference to FIGS. 12A and 12B where components which are the same
or perform similar functions as those discussed earlier are labeled
the same. As shown, container holder 4 for this embodiment has a
receptacle end 6 whose outer circumferential portion has external
threads 110 and whose inner circumference is threaded with internal
threads 42. As shown in FIG. 12A, needle assembly 20 containing
cannulas 22 and an opposed cannula 24 (not shown in FIG. 12A since
it is covered by rubber sheath 32) is threadedly mated to internal
threads 42 of receptacle end 6 via its threaded portion 30. The
needle assembly is shown has having a needle hub 26 enveloping a
portion of cannula 22. For the FIG. 12A embodiment, it should
further be noted that needle hub 26 has a number of rib members
112a to 112d each extending orthogonally away from cannula 22.
As best shown in both FIGS. 12A and 12B, this embodiment of the
present invention has a housing 18 that has a housing portion 18a
extending from a base portion 18b. The portion of the housing
designated 114 (best shown in FIG. 12B) is made of a material more
flexible than housing 18, or a living hinge such as 16 shown in
FIG. 1, so that housing portion 18a can pivot along the directions
as indicated by bi-directional arrows 116.
As shown, base portion 18b of housing 18 has internal threads 116
for threadedly mating with threads 110 of receptacle end 6 of
container holder 4. Bas portion 18b further has an aperture 118
which comes into alignment with opening 5 of receptacle end 6 when
base portion 18b is threadedly mated to receptacle end 6.
As should be appreciated, housing 18 has to be first threadedly
mated to container holder 4, via threads 116 of base 18b and
threads 110 of receptacle end 6, before the needle assembly is
threaded through aperture 118 into opening 5 of receptacle end 6.
As should further be appreciated, once base 18b of housing 18 has
been securely mated to receptacle end 6 of container holder 4,
housing portion 18a has to be biased away from longitudinal axis 12
along the direction indicated by directional arrow 116a in order to
permit threaded portion 30 of the needle assembly to be threaded
into opening 5 of receptacle 6. Assuming that housing portion 18a
remains biased away from cannula 22, once the needle assembly has
been assembled as shown in FIGS. 12A and 12B, the insertion of
container tube 36 into opening 34 of container holder and the
subsequent transferring of fluid between the patient and the
container tube 36 via cannula 22 proceeds a described previously
with the earlier embodiments. Once the transfer of fluid has been
completed, to prevent the user or bystander from being accidentally
exposed to contaminated tip 98 of cannula 22, housing portion 18a
is pivoted along the direction indicated by directional arrow 116b
into substantial alignment along longitudinal axis 12 of the needle
assembly. As was discussed before, mechanism 44 of housing portion
18a will retain cannula 22 within the housing portion, i.e. in the
space between finger 44a and extension 44c as shown in FIG.
12c.
After cannula 22 has been retained in place, both housing 18 and
the needle assembly are removed together from container holder 4
such that container holder 4 may be reused. One example method of
ensuring that both housing 18 and the needle assembly are removed
as a unit is to have at least one flange member 120 (seen in FIG.
12b) extending internally from housing portion 18a toward rib
member 112d, so that, as base 18b is unthreaded from receptacle end
6, flange member 120 would come into contact alignment with one of
the rib members of the needle hub 26, for example rib member 112d.
And as base portion 18b is further unthreaded from receptacle end
6, the needle assembly is forced by the contact engagement of rib
member 112b and flange member 120 to turn in the same direction as
base portion 18b. Accordingly, the needle assembly is unthreaded
from the container holder together with housing 18. The thus
removed combination housing 18 and needle assembly is of course
disposed of in the usual manner.
FIGS. 13A to 13C illustrate a variant of the FIG. 12 embodiment
whereby a cap portion 18c is jointed to housing portion 18a by a
collapsible section 122, which is similar to section 90 of the
housing shown in FIG. 5A. The operation of the FIG. 13 embodiment
is the same as the FIG. 12 embodiment but for the fact that once
cannula 22 has been securely retained within housing portion 18a by
locking mechanism 44, relative movement between housing portion 18a
and cap portion 18c is effected toward each other to collapse
collapsible section 122 to thereby force tip 98 to pierce into
sealing member 94 adapted to cap portion 18c. Tip 98 is accordingly
securely retained within sealing member 94.
Yet another variant of the FIG. 12 embodiment is illustrated in
FIGS. 14A and 14B where it can be seen that external threads 110 of
receptacle end 6 and internal threads 116 of base portion 18b (as
shown in FIGS. 13A and 13B) have been eliminated. Instead, the
outer circumference of receptacle end 6 matches very closely to the
inner circumference of base portion 18b of housing 18, such that
base 18b may be fittingly mated with the outer circumferential
portion of receptacle end 6. With the threading of threaded portion
30 of the needle assembly into aperture 118 of base portion 18b and
opening 5 of receptacle end 6, base portion 18b is substantially
guaranteed to stay in place, until the combination housing 18 and
needle assembly is unthreaded from container holder 4.
With reference to the housing shown in FIGS. 5A-5C and specifically
to the embodiments illustrated in FIGS. 6-14, it should be
appreciated that the protective device of the instant invention is
able to doubly prevent the accidental pricking of a user, or a
bystander, by a contaminated needle, inasmuch as the protective
device is able to, first, substantially permanently retain the
contaminated needle by a protective housing, and, secondly, provide
for the sealingly retention of the tip of the contaminated
needle.
Inasmuch as the present invention is subject to many variations,
modifications and changes in detail, it is intended that all matter
described throughout this specification and shown in the
accompanying drawings be interpreted as illustrative only and not
in a limiting sense. Accordingly, it is intended that the invention
be limited only by the spirit and scope of the hereto appended
claims.
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